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NCT Number: NCT03215368

The Ma'Anshan Birth Cohort (MABC)

The Ma'anshan Birth Cohort (MABC) is a population-based prospective pregnancy and birth cohort study that aims to explore the early environmental and genetic determinants of maternal and child health, with a focus on health outcomes including maternal health, children's cognitive and behavioral development, growth and physical development, video-screen behaviors, and asthma and allergic diseases.

MABC was officially launched in May 2013 at the Ma'anshan Maternal and Child Health Hospital in Anhui Province, and a total of 3,474 families were recruited as of September 2014 to continuously track the health status of mother-child pairs during pregnancy, delivery, and childhood, including basic family demographics, maternal pregnancy and birth history and past history, history of exposure to hazardous factors during pregnancy, children's diets and lifestyles, and children's physical and cognitive-behavioral development, MABC quantifies the attributional relationship between environmental chemicals, diet and nutrition, drug safety, psychological stress, lifestyle, biorhythm, endocrine metabolism and adverse birth outcomes, birth defects, neurodevelopmental disorders, developmental disabilities, etc., and identifies environmental, behavioral and genetic causative factors for birth defects and common developmental disorders, and identifies early warning signs and symptoms for early detection of birth defects. genetic causative factors, identify clinical biomarkers with early predictive effects, integrate and form a precise risk evaluation and early warning model, carry out regional comprehensive prevention and treatment applications, and promote the improvement of the quality of the birth population. Currently, MABC is conducting its 20th school-age follow-up visit.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Environmental Exposure Birth Defects Child Development Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Health Problems in Pregnancy Maternal and Child Health Pregnancy Outcome

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Ma'anshan Maternal and Child Health Care Hospital

Ma’anshan, Anhui, 243011, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Permanent residents of Ma'anshan city;
  • Obstetric examination and delivery at Ma'anshan Maternal and Child Health Hospital;
  • Mother's age ≥ 18 years old and gestational week ≤ 14 weeks;
  • No serious neuropsychiatric disorders, with sufficient understanding and expression to complete the survey.

Exclusion criteria

  • Intellectual disability or other serious mental disorders;
  • Suffering from serious underlying diseases and may have a significant impact on pregnancy outcome;
  • Those with poor compliance and difficulty in follow-up.

Treatment and study plan

Primary outcomes

  1. Numbers of participants with pregnancy complications

    Time frame: At delivery

    Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy.

    Diagnosis by medical personnel at clinics

  2. Numbers of participants with adverse pregnancy outcomes

    Time frame: At delivery

    Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.

    Hospital information system collection

Secondary outcomes

  1. Weight in kilogram changes during childhood

    Time frame: At birth and age at 42 days, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11years and 12 years

    Measured by health professionals in the clinic.

  2. Height in centimeter changes during childhood

    Time frame: At birth and age at 42 days, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11years and 12 years

    Measured by health professionals in the clinic.

  3. Early Child development

    Time frame: Age at 6 months, 48 months and 54 months

    Measured by Ages&Stages Questionnaires (ASQ). There are 6 questions in each of 5 domains of development: communication, gross motor, fine motor, problem-solving skills, and adaptive skills. Each question is given a 10 (yes), 5 (sometimes), or 0 (not yet) score according to the parents' answers. The sum scores (range from 0 to 300) and scores for each domain (range from 0 to 60) are calculated. Chinese norms are available for each domain, and any domain screened <2 SDs below the mean is considered a positive screening. A higher ASQ score means better development.

  4. Child Psychological and Behavioural Development

    Time frame: Age at 48 months, 60 months and 72 months

    Measured by Strengths and Difficulties Questionnaire(SDQ). SDQ consisted of 25 entries scored on a 3-point scale from 0 to 2. 0: "Doesn't meet"; 1: "Somewhat meets"; 2: "Completely meets"; and the results were summarized into 5 factors: emotional factor, conduct factor, hyperactivity factor, peer factor, and pro-social factor, each with a score range of 0 to 10. The results were categorized into five factors: Emotional, Conduct, Hyperactivity, Peer, and Pro-social, each of which has a score range of 0-10 points. The sum of the scores of the first four factors is the total difficulty score of the SDQ, and the higher the score, the more serious the objective difficulty is. The higher the score, the better the pro-social ability.

  5. Child Intelligence quotient

    Time frame: At age of 54 months

    Assessed by using Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition-Chinese (WPPSI-IV（CN）), which can generate a full scale intelligence quotient score and five primary index scores including verbal comprehension, visual spatial, fluid reasoning, working memory, and processing speed. Intelligence quotient ranges from 40 to 160, in which less than 70 is defined as mental retardation

  6. Child Sexual Development Indicators

    Time frame: At ages of 9-15 years for boys, and 8-14 years for girls

    Secondary sexual characters, Sexual hormones. Staging of puberty using Tanners classification: Testicular size of boys assessed by Prader's testerometer suggests possible precocious puberty if testicular development occurs before the age of 9 years in boys, and if breast development occurs before the age of 7.5 years or first menstruation occurs before the age of 10 years in girls. In order to further determine the existence and classification of precocious puberty, ultrasound examination of the uterus and ovaries for girls and ultrasound examination of the testes for boys are required. In addition to the above tests, bone age assessment, bone density test, adrenal gland ultrasound, thyroid function, sex hormone 6, alpha-fetoprotein measurement, growth hormone stimulation test and gonadotropin-releasing hormone stimulation test are also performed to further confirm the diagnosis.

  7. Incidence of child overweight and obesity

    Time frame: At birth and age at 42 days, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 3.5 years, 4 years, 4.5years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11years and 12 years

    Measured by health professionals in clinic.

  8. Fetal Head Circumference

    Time frame: At delivery.

    Measured by health professionals in clinic with ultrasound.

  9. Fetal Abdominal Circumference

    Time frame: At delivery.

    Measured by health professionals in clinic with ultrasound.

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Collaborators

  • Ma'anshan Maternal and Child Health Care Hospital

Registry information

Official study title

A Population-Based Prospective Cohort Study to Examine the Effects of Maternal Pregnancy Exposure on Adverse Pregnancy Outcomes, Child Health and Their Development.

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2017
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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